No registrations found.
ID
Source
Brief title
Health condition
scar related ventricular tachycardia
dutch: ventrikel tachycardie
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study endpoint is the difference in recurrences of ventricular tachycardia on follow-up - clinical or on ICD interrogation - between the two ablation groups
Secondary outcome
The secondary endpoints are procedure success and safety
Background summary
The objective of this study is to show superiority of a combined endo/epicardial approach compared to a stepwise approach in the ablation of ventricular tachycardia in a population with ischemic cardiomyopathy on VT recurrence.
Study design: Multicenter prospective open randomized controlled trial.
Study population: All patients above 18 years with an ischemic cardiomyopathy being referred for a ventricular tachycardia ablation.
Study objective
We hypothesise endo/epicardial substrate homogenization in a first approach to be superior to endocardial substrate homogenization alone, in terms of recurrence on follow-up.
Study design
2 years follow-up
Intervention
One group undergoes endo/epicardial ablation and the other group has endocardial ablation only as a first approach.
Astrid Hendriks
‘s Gravendijkwal 230
Rotterdam 3015 CE
The Netherlands
+31-10-7033318
a.a.hendriks@erasmusms.nl
Astrid Hendriks
‘s Gravendijkwal 230
Rotterdam 3015 CE
The Netherlands
+31-10-7033318
a.a.hendriks@erasmusms.nl
Inclusion criteria
1. clinical indication for ablation of a monomorphic ventricular tachycardia referred to one of the participating ablation centers
2. history of ischemic heart disease
3. ICD carrier or ICD implantation planned after the ablation
4. informed written consent
Exclusion criteria
1. current unstable angina as defined by current european guidelines
2. AMI < 30 days or in case of incessant VT < 14 days
3. absence of visualisation of the coronary anatomy (coronary angiogram /CT-angiogram)
4. significant coronary stenosis approachable and clinically relevant for intervention
5. presence of a mobile left ventricle thrombus seen on (contrast) echocardiograpy or MRI
6. previous pericarditis
7. presence of mitral/aortic mechanical valves prosthesis; previous coronary artery bypass graft; any other thoracic surgery that could cause pericardial adhesions
8. previous thoracic radiation therapy
9. contra-indication for general anaesthesia
10. age below 18 years
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL4989 |
| NTR-old | NTR5136 |
| Other | MEC : 2014-248 |